Effectiveness of antenatal screening of asymptomatic bacteriuria in reduction of prematurity and low birth weight: Evaluating a point-of-care rapid test in a pragmatic randomized controlled study

Manish Gehani; Suman Kapur; Sudha D Madhuri; Vara Prasad Pittala; Sree Kala Korvi; Nagamani Kammili; Shashwat Sharad

doi:10.1016/j.eclinm.2021.100762

Effectiveness of antenatal screening of asymptomatic bacteriuria in reduction of prematurity and low birth weight: Evaluating a point-of-care rapid test in a pragmatic randomized controlled study

EClinicalMedicine. 2021 Mar 2:33:100762. doi: 10.1016/j.eclinm.2021.100762. eCollection 2021 Mar.

Authors

Manish Gehani¹, Suman Kapur¹, Sudha D Madhuri², Vara Prasad Pittala³, Sree Kala Korvi⁴, Nagamani Kammili², Shashwat Sharad⁵

Affiliations

¹ Department of Biological Sciences, Birla Institute of Technology and Science, Pilani, Hyderabad Campus, Hyderabad 500078, India.
² Department of Microbiology, Gandhi Medical College and Hospital, Secunderabad 500003, India.
³ Jhpiego, Hyderabad 500038, India.
⁴ Independent Consultant, Hyderabad, 500038, India.
⁵ Center for Prostate Disease Research, John P. Murtha Cancer Center Research Program, Department of Surgery, Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, MD, United States.

Abstract

Background: Premature babies suffer higher mortality and life-long disabilities. Asymptomatic bacteriuria (ASB) is postulated to induce preterm labor. Routine antenatal screening for ASB using urine culture is not feasible in most developing countries due to long turn-around time, user-unfriendliness, and lack of resources. The current parallel-group superiority pragmatic randomized controlled trial evaluated the effect of screening and evidence-based treatment of ASB using an optical-sensor-based point-of-care rapid-test on the incidence of preterm birth and low birthweight (LBW).

Methods: 240 consenting asymptomatic pregnant women visiting an Indian tertiary public hospital for first antenatal check-up, irrespective of trimester/gravida, who had not consumed antibiotics in the preceding week, were enrolled from February-May 2017. Computer-generated concealed simple randomization allocation sequence was used to assign participants to intervention (120) and control arm (120). Usual hospital-care was provided in the control arm. In the intervention arm, urine samples were additionally screened for ASB using the rapid-test and the positive women were prescribed susceptible antibiotics. Blinded outcome assessors followed up with women post-delivery. The study was registered with the Clinical Trials Registry-India (CTRI/2016/09/007240).

Findings: 213 participants were analyzed (intervention: 103, control: 110). 21 women were found positive for ASB and prescribed pathogen-specific antibiotics. The incidence of preterm birth/LBW in intervention arm (n = 27) was lower than control arm (n = 45) by 14·7% (95% CI: 2·2-27·2); RR: 0.64, (95% CI: 0·43-0·95); p = 0·023, X²=5·13.

Interpretation: Rapid-test-guided treatment for ASB reduced the incidence of preterm birth/LBW in a pragmatic setting without any adverse event.

Funding: Department of Biotechnology, Government of India.

Keywords: Asymptomatic bacteriuria; Low birth weight; Point-of-care test; Pragmatic randomized controlled trial; Pregnant women; Preterm birth; Rapid test.